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Jubilant Life Sciences Ltd receives USFDA warning letter for Roorkee Facility, India

Posted On: 2019-03-08 13:16:17

Jubilant Lifesciences Limited (JLL), an integrated global Pharmaceuticals and Life Sciences company, has announced that in Jubilant Pharma Limited (JPL), its material wholly owned subsidiary, with reference to the USFDA inspection conducted at one of manufacturing facility at Roorkee, India of solid dosage formulations during August 2018 and the subsequent intimation from the agency of classifying the facility as "Official Action Indicated" (OAI) in December 2018, the agency has further issued a Warning letter for the Roorkee facility. The USFDA may withhold approval of any new applications or supplements till the company addresses all issues raised by the agency. However, we believe that the existing manufacturing and sale of products from this facility will not be impacted. US revenues from the facility is about 4% of the total revenues of the company.

The company is committed to implementing the necessary corrective actions required to address USFDA concerns and is in the process of providing a thorough and comprehensive response to the USFDA within 15 working days.

Shares of JUBILANT LIFE SCIENCES LIMITED was last trading in BSE at Rs.783.9 as compared to the previous close of Rs. 765.85. The total number of shares traded during the day was 716425 in over 2438 trades.

The stock hit an intraday high of Rs. 794 and intraday low of 766. The net turnover during the day was Rs. 549927161.


Source: Equity Bulls

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